510(k) · Cleared
ClearedHyperglide and Hyperform Occlusion Balloon Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics Dba Ev3 Neurovascular · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Jul 13, 2010 as substantially equivalent to K990487 (Micro Therapeutics, Inc., 1999) and 9 other predicates after a 39-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.
- Decided
- Jul 13, 2010
- Review
- 39 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 4 generations to K011526 (2001). 10 ancestors in all, the oldest K990487 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK011526 Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121…Micro Therapeutics, Inc. · 2001
- 3 generations backK090728 Hyperglide Occlusion Balloon SystemEv3, Inc. · 2009
- 2 generations backK092495 Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315Ev3 Neurovascular · 2009
- 1 generation backK100063 Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon…Ev3, Inc. · 2010
- This deviceK101570 Hyperglide and Hyperform Occlusion Balloon SystemsMicro Therapeutics Dba Ev3 Neurovascular · 2010
- Descendant · cites it directly · 0 of its ownK122576 Transform Occlusion Balloon Catheter (Compliant and Super CompliantStryker Neurovascular · 2013 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K122576Transform Occlusion Balloon Catheter (Compliant and Super CompliantStryker Neurovascular · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011526 | Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121, 104-4129… | Micro Therapeutics, Inc. | 2001 | — |
| −3 | K090728 | Hyperglide Occlusion Balloon System | Ev3, Inc. | 2009 | — |
| −2 | K092495 | Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315 | Ev3 Neurovascular | 2009 | — |
| −1 | K100063 | Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter… | Ev3, Inc. | 2010 | — |
| 0 (this device) | K101570 | Hyperglide and Hyperform Occlusion Balloon Systems | Micro Therapeutics Dba Ev3 Neurovascular | 2010 | — |
| +1 | K122576 | Transform Occlusion Balloon Catheter (Compliant and Super Compliant | Stryker Neurovascular | 2013 | 8 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MJN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MJN device
- #1 K243795 pREBOA-PRO Catheterscore 12.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (10)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990487 | Equinox Occlusion Balloon SystemSummary page 1…Devices The ev3 Occlusion Balloon Catheters are substantially equivalent to the previously cleared occlusion balloon catheters cleared under 51 0(k)s K990487, K001 237, K010162, K01 1526. K01 1656, K021066, K090728, K091458, K092495 and Ki 00063. IV. Device Des… | 1999 |
| * | K001237 | Equinox Occlusion Balloon Catheter/System - (10MM Balloon, 4 & 13 MM Tip), (15 MM…Summary page 1…The ev3 Occlusion Balloon Catheters are substantially equivalent to the previously cleared occlusion balloon catheters cleared under 51 0(k)s K990487, K001 237, K010162, K01 1526. K01 1656, K021066, K090728, K091458, K092495 and Ki 00063. IV. Device Description… | 2000 |
| * | K010162 | Equinox Occulsion Balloon System Model # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026Summary page 1…lusion Balloon Catheters are substantially equivalent to the previously cleared occlusion balloon catheters cleared under 51 0(k)s K990487, K001 237, K010162, K01 1526. K01 1656, K021066, K090728, K091458, K092495 and Ki 00063. IV. Device Description The ev3 Occ… | 2001 |
| * | K011526 | Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121, 104-4129, 104-4126…Summary page 1…lloon Catheters are substantially equivalent to the previously cleared occlusion balloon catheters cleared under 51 0(k)s K990487, K001 237, K010162, K01 1526. K01 1656, K021066, K090728, K091458, K092495 and Ki 00063. IV. Device Description The ev3 Occlusion Bal… | 2001 |
| * | K011656 | Hyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771Summary page 1…eters are substantially equivalent to the previously cleared occlusion balloon catheters cleared under 51 0(k)s K990487, K001 237, K010162, K01 1526. K01 1656, K021066, K090728, K091458, K092495 and Ki 00063. IV. Device Description The ev3 Occlusion Balloon Cathe… | 2001 |
| * | K021066 | Modification to Hyperglide Occlusion Balloon SystemSummary page 1…substantially equivalent to the previously cleared occlusion balloon catheters cleared under 51 0(k)s K990487, K001 237, K010162, K01 1526. K01 1656, K021066, K090728, K091458, K092495 and Ki 00063. IV. Device Description The ev3 Occlusion Balloon Catheters are… | 2002 |
| * | K090728 | Hyperglide Occlusion Balloon SystemSummary page 1…ally equivalent to the previously cleared occlusion balloon catheters cleared under 51 0(k)s K990487, K001 237, K010162, K01 1526. K01 1656, K021066, K090728, K091458, K092495 and Ki 00063. IV. Device Description The ev3 Occlusion Balloon Catheters are single lu… | 2009 |
| * | K091458 | Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112…Summary page 1…valent to the previously cleared occlusion balloon catheters cleared under 51 0(k)s K990487, K001 237, K010162, K01 1526. K01 1656, K021066, K090728, K091458, K092495 and Ki 00063. IV. Device Description The ev3 Occlusion Balloon Catheters are single lumen, open… | 2009 |
| * | K092495 | Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315Summary page 1…the previously cleared occlusion balloon catheters cleared under 51 0(k)s K990487, K001 237, K010162, K01 1526. K01 1656, K021066, K090728, K091458, K092495 and Ki 00063. IV. Device Description The ev3 Occlusion Balloon Catheters are single lumen, open-ended ba… | 2009 |
| * | K100063 | Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter, Hyperglide… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122576 | Transform Occlusion Balloon Catheter (Compliant and Super Compliant | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 5 months on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K122576 (Stryker Neurovascular, 2013) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K990487.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MJN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MJN
116in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MJN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJN
194in 2025
MAUDE reports naming product code MJN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 25 |
| 2008 | 3 | 153 | 2 | 26 |
| 2009 | 5 | 39 | 0 | 25 |
| 2010 | 5 | 30 | 1 | 35 |
| 2011 | 4 | 69 | 1 | 92 |
| 2012 | 2 | — | 0 | 53 |
| 2013 | 4 | 87 | 8 | 76 |
| 2014 | 2 | — | 0 | 100 |
| 2015 | 4 | 245 | 1 | 90 |
| 2016 | 3 | 110 | 2 | 71 |
| 2017 | 3 | 54 | 0 | 157 |
| 2018 | 3 | 63 | 1 | 107 |
| 2019 | 3 | 117 | 0 | 139 |
| 2020 | 4 | 64 | 1 | 157 |
| 2021 | 4 | 116 | 0 | 158 |
| 2022 | 2 | — | 0 | 148 |
| 2023 | 1 | — | 0 | 181 |
| 2024 | 0 | — | 0 | 224 |
| 2025 | 2 | — | 0 | 194 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ev3 Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer a selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow; the Occlusion Balloon Catheters may also be used in balloon-assisted embolization of intracranial aneurysms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101570 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101570: Hyperglide and Hyperform Occlusion Balloon Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101570
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026